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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

NCTNCT01147627 (opens ClinicalTrials.gov in a new tab)Other idIIT-201007-WJP
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
416 participants (actual)
Sponsor
Sun Yat-sen University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Aug 2010
Primary completion
Aug 2012
Completion
Dec 2012
First posted
22 Jun 2010 (estimated)
Last update posted
21 Aug 2013 (estimated)
Conditions
Diabetes Mellitus, Type 2 · Newly Diagnosed

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. N/A

    Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

    NCT01147627

    Aug 2010 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Interventions

  • exenatide injectionDrug
  • Mixed Protamine Zinc Recombinant Human Insulin Lispro 25RDrug
  • PioglitazoneDrug

Arms3

  • Active comparator

    Exenatide

  • Active comparator

    Premixed insulin analog

  • Active comparator

    pioglitazone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks

    Time frame · 48 weeks

Secondary outcomes(3)

  1. Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles

    Time frame · 48 weeks

  2. β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)

    Time frame · 48 weeks

  3. Safety and Tolerability in Different Groups

    Time frame · 48 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 48 weeks

the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks

GroupValue (percentage of HbA1c)Spread
Exenatide-1.81.29
Premixed Insulin Analog-1.741.16
Thiazolidinedione-1.471.30
Secondary and other outcome results(3)
Secondary outcome· 48 weeks

Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles

GroupValue
Secondary outcome· 48 weeks

β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio)

GroupValue
Secondary outcome· 48 weeks

Safety and Tolerability in Different Groups

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide–5 / 14269 / 142
Premixed Insulin Analog–1 / 13842 / 138
Thiazolidinedione–7 / 13643 / 136

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * newly-diagnosed type 2 diabetic patients, drug naïve * age 30\~70 years * HbA1c 7.0\~10.0% * BMI 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening * female patients of reproductive age should practice a reliable method of birth control throughout the study Exclusion Criteria: * acute or severe chronic diabetic complications * congestive heart failure (NYHA grade Ⅲ\~Ⅳ) * severe gastrointestinal disease * severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation * other severe intercurrent illness * serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL) * tested positive for glutamic acid decarboxylase antibody * use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug * history of pancreatitis * serum triglyceride ≥ 5.0 mmol/L * pregnancy

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